Application 205136

Type: ANDA
Sponsor: INDICUS PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	TABLET;ORAL	12.5MG	No	No
002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205136-001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2019-02-22
A205136-002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2019-02-22
A205136-003	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2019-02-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A205136-003	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205136-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2019-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205136-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2019-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205136-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2019-02-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205136-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2019-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205136-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2019-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205136-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2019-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205136-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2019-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205136-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2019-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205136-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2019-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205136-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2019-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205136-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2019-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205136-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2019-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205136-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2019-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205136-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2019-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205136-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2019-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205136-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2019-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205136-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2019-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205136-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2019-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205136-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2019-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205136-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2019-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205136-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2019-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205136-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2019-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205136-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2019-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205136-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2019-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205136-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2019-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205136-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2019-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205136-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2019-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205136-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2019-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205136-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2019-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205136-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2019-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205136-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2019-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205136-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2019-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205136-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2019-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205136-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2019-02-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205136-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2019-02-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205136-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2019-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205136-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2019-02-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205136-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2019-02-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205136-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2019-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205136-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2019-02-22	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 85 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205136-003	AA	1	`caaa826d4ba7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205136-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205136-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205136-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205136-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205136-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205136-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205136-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205136-002	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205136-003	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205136-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205136-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205136-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205136-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205136-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205136-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205136-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205136-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205136-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205136-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205136-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205136-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205136-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205136-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205136-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205136-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205136-003	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205136-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205136-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205136-003	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205136-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205136-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205136-003	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205136-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205136-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205136-003	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205136-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205136-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205136-003	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205136-001	AA	1	`3f01610625f2…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MECLIZINE HYDROCHLORIDE	MECLIZINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b11c10b9-f40e-4ea7-9c5d-118517049f9d	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205136 application number: ANDA205136

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52536-129	Meclizine hydrochloride	Meclizine hydrochloride	Wilshire Pharmaceuticals Inc	ANDA	Current
52536-129	Meclizine hydrochloride	Meclizine hydrochloride	Wilshire Pharmaceuticals Inc	ANDA	Current
52536-133	Meclizine hydrochloride	Meclizine hydrochloride	Wilshire Pharmaceuticals Inc	ANDA	Current
52536-133	Meclizine hydrochloride	Meclizine hydrochloride	Wilshire Pharmaceuticals Inc	ANDA	Current
52536-137	Meclizine hydrochloride	Meclizine hydrochloride	Wilshire Pharmaceuticals Inc	ANDA	Current
52536-137	Meclizine hydrochloride	Meclizine hydrochloride	Wilshire Pharmaceuticals Inc	ANDA	Current
71205-374	Meclizine hydrochloride	Meclizine hydrochloride	Proficient Rx LP	ANDA	Current
71205-374	Meclizine hydrochloride	Meclizine hydrochloride	Proficient Rx LP	ANDA	Current